Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass (GLP-1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Cincinnati
Sponsor:
Information provided by (Responsible Party):
Marzieh Salehi, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01803451
First received: February 20, 2013
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

The overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism.

The central hypothesis guiding this project is that the reconfiguration of intestinal transit with the Roux-en-Y will increase the release of insulinotropic GI hormones, termed incretins that improve insulin secretion and glucose metabolism. The study is divided into three specific aims.

  1. To determine the role of incretin hormones on insulin secretion in patients with gastric bypass surgery using intravenous-oral hyperglycemic clamp.
  2. To compare incretin effect and glucose tolerance among patient who suffer from hypoglycemia after RYGB and asymptomatic surgical and non-surgical individuals.
  3. To quantify the contribution of GLP-1 to incretin effect enhancement following surgery.

Condition Intervention Phase
Post-bariatric Surgery
Drug: exendin-(9-39)
Drug: exendin -(9-39)
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Official Title: The Role of Glucagon Like Peptide-1 in Glucose Metabolism and Weight Loss Following Gastric Bypass Surgery

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • The investigator measure glucose, islet and GI hormonal levels in response to meal ingestion as a composite measure and the percentage of contribution of GLP-1 contribution to postprandial insulin levels will also be calculated [ Time Frame: up to 1 year (10 sessions) ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2005
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hyperglycemic clamp-Meal tolerance test
these studies are to evaluate the effect of exendin-9 on insulin secretion before and after meal ingestion in patients after bariatric surgeries compared to non-surgical controls
Drug: exendin-(9-39)
hyperglycemic clamp-meal tolerance test is designed to assess insulin secretion before and after meal ingestion
Experimental: Labeled meal tolerance test
The effect of GLP-1 receptor blockade on glucose tolerance and glucose kinetics are evaluated in the group patients with bariatric surgery vs. nonsurgical using exendin-9-39 infusion during one of the the 2-day dual tracer studies of meal tolerance test
Drug: exendin -(9-39)
2-day meal tolerance tests with labeled oral and IV glucose using exendin-(9-39) infusion are designed to evaluate the role of GLP-1 signaling on glucose tolerance and glucose kinetics.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18-65
  • healthy control without diabetes or active organ disease
  • Individuals with bariatric surgery
  • recurrent hypoglycemia post gastric bypass

Exclusion Criteria:

  • pregnancy
  • significant anemia
  • diabetes currently unless pre-op for bariatric surgery procedure
  • GI obstruction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803451

Contacts
Contact: Carol A Colegate, RPh 513-558-0201 colegaca@uc.edu
Contact: Marzieh Salehi, MD 513-558-0001 marzieh.salehi@uc.edu

Locations
United States, Ohio
The University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Carol A Colegate, RPh    513-558-0201    colegaca@uc.edu   
Principal Investigator: Marzieh Salehi, MD         
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Marzieh Salehi, MD University of Cincinnati
  More Information

No publications provided by University of Cincinnati

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marzieh Salehi, Marzieh Salehi MD, MS, FACP Assistant Professor of Medicine, University of Cincinnati College of Medicine Division of Endocrinology, Diabetes and Metabolism, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01803451     History of Changes
Other Study ID Numbers: 05-09-28-01
Study First Received: February 20, 2013
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Cincinnati:
gastric bypass
glucose metabolism
hypoglycemia

Additional relevant MeSH terms:
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins

ClinicalTrials.gov processed this record on August 28, 2014